Prescription drug · BLA
Tyenne (Tocilizumab-aazg) NDC 65219-592
Tocilizumab 200 mg/10mL · Injection, Solution, Concentrate · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-592-10 | 65219059210 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-592-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tyenne
- Generic name (nonproprietary)
- tocilizumab-aazg
- Active ingredients
- Tocilizumab — 200 mg/10mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761275
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin 6 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65219-592_363d125e-6d69-4bb2-ae09-5eeb5d9edbaeSPL ID 363d125e-6d69-4bb2-ae09-5eeb5d9edbaeSPL set ID e400bbe6-43c5-4de6-82b9-cb44ce3cd906RxCUI 2679431, 2679438, 2679440, 2679441, 2679442, 2679443UNII I031V2H011
- Pharmacologic class
- Interleukin-6 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465219059210followed by a unit qualifier and the quantityPackage 65219-0592-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
TYENNE ® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) • Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release …
Excerpt only. Read the full label for complete information.
About NDC 65219-592
- What is NDC 65219-592?
- 65219-592 is the product NDC for Tyenne (tocilizumab-aazg), Tocilizumab 200 mg/10mL injection, solution, concentrate, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tyenne (Tocilizumab-aazg).
- What is the active ingredient?
- Tocilizumab.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tyenne?
- 6 other product NDCs are listed under this name. See all Tyenne NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tyenne products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-596 | 65219-0596-01 |
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-598 | 65219-0598-10 |
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-584 | 65219-0584-01 |
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-586 | 65219-0586-04 |
| Tyennetocilizumab-aazg | Tocilizumab 80 mg/4mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-590 | 65219-0590-04 |
| Tyennetocilizumab-aazg | Tocilizumab 400 mg/20mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-594 | 65219-0594-20 |
Other NDCs under BLA 761275
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-584 |
| Tyennetocilizumab-aazg | Tocilizumab 162 mg/.9mL | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 65219-586 |
| Tyennetocilizumab-aazg | Tocilizumab 80 mg/4mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-590 |
| Tyennetocilizumab-aazg | Tocilizumab 400 mg/20mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 65219-594 |